510(k) · Cleared
ClearedAVEA disposable expiratory filter/water trap (11790)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telesair, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on May 8, 2025 as substantially equivalent to K081837 (Cardinal Health 207, Inc., 2008) after a 27-day review. Its family tree reaches back 6 generations to 1991. 2 of the 24 devices in its family, counting itself, have a Class I recall.
- Decided
- May 8, 2025
- Review
- 27 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K902859 (1991). 23 ancestors in all, the oldest K895541 (1990). No later device cites it as a predicate yet. 2 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 4 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 3 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 2 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 1 generation backK081837 Avea VentilatorCardinal Health 207, Inc. · 2008
- This deviceK251133 AVEA disposable expiratory filter/water trap (11790)Telesair, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −5 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −4 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −3 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −2 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −1 | K081837 | Avea Ventilator | Cardinal Health 207, Inc. | 2008 | — |
| 0 (this device) | K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 1 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081837 | Avea VentilatorSummary page 6…ble Expiratory Filter/ Water Trap Expiratory Filter/ Water Trap K# K081837 TBD Product Code CBK… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 5.5 years on median.
- 7 of the 23 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K081837.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator.
It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients.
It should be operated by properly trained clinical personnel, under the direction of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251133 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251133: AVEA disposable expiratory filter/water trap (11790).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251133
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026